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Indegene

Indegene Fast Tracks Canadian Annual Summary Reports (ASRs) Submission for Class IV Medical Devices

The Customer

A multinational healthcare services and products company that specializes in the distribution of medical, surgical, and laboratory products. Their offerings include a broad range of medical devices, pharmaceuticals, and clinical products and were exploring assistance in ASR submission for class IV medical devices in Canada

The Need

  • Client required a partner to collaborate and develop new Canadian Annual Summary Reports(ASRs) for two Class IV products as per Canadian Medical Devices Regulations (CMDR) (SOR-98-282) with a stringent timeline of 8 weeks.​

    The ASR document required mapping of 200+ hazards with the product risk management files plus analysis of 100+ complaints from raw data.​

The Solution

A highly qualified team of medical writers and medical reviewers assigned to the project with a goal to meet the 8 weeks turnaround time.

Based on the team’s in-depth knowledge on Canadian Regulations, provided value based inputs to enhance the client’s ASR template.

The team of medical writers and reviewers served as the SMEs for end-to-end ASR authoring, addressing gaps in client’s source documents, and collaborating efficiently with the client’s cross-functional team.​

Conducted a very comprehensive literature surveillance review right from defining the search strategy to literature summarization and extraction of data for the hazards and hazardous situations to map to the risk files.​

Also, accurately analyzed the complaints data to compile the incidents rate and hazards table for comparison with the product risk management file and categorized 200+ hazards to 60 high level hazards for ease of mapping.

Outcomes

25-30%

Productivity enhancement through new process implementation

100%

First Time Right Draft Acceptance

100%

compliance to CMDR (SOR-98-282) requirements